In 2014, the New York State Task Force on Life and the Law, the state’s bioethics commission, will release its updated Allocation of Ventilators in an Influenza Pandemic, which enunciate a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. These guidelines are the product of seven years of hard work by the Task Force and its staff and were developed by incorporating comments, critiques, feedback, and values from numerous stakeholders. They draw upon the expertise of multiple workgroups and committees with special knowledge in scarce resource allocation, pediatric and neonatal medicine, ethics, law, and policy. The 2014 version of these guidelines will not only include an updated clinical protocol for allocation of ventilators to adults; they will also include first of their kind protocols for allocation of ventilators to two important and previously unaddressed segments of the population: pediatric patients and neonates.

I have had the great fortune to continue serving the Task Force in finalizing these Guidelines. In particular, the brief summary on legal issues from the 2007 draft guidelines has been replaced with a more substantial exploration of the various legal issues that may arise when implementing the clinical protocols for ventilator allocation.

Of primary concern to the Task Force in its deliberations was the effective implementation of the clinical allocation protocols, which could be stymied by health care workers’ reluctance to follow the guidelines due to concerns about liability. The financial, time, and reputational costs of defending a criminal prosecution, civil lawsuit, or professional disciplinary proceeding, as well as conflicting laws and regulations, all may make abiding by the clinical protocols particularly challenging.

All states and the federal government have procedures by which a person – usually either the Governor or the Health Commissioner – may declare a public health emergency or disaster. In general, the emergency powers conferred by an emergency declaration may include the provision of statutory liability protections for health care workers who provide care during a declared state of emergency. A previously published article Unique Proposals for Limiting Legal Liability and Encouraging Adherence to Ventilator Allocation Guidelines in an Influenza Pandemic, addresses the issue of liability for health care workers and entities who adhere to the clinical protocol contained in the Ventilator Guidelines while rendering care in a disaster emergency. In that piece, we recommend legislation granting adequate civil and criminal liability protections to health care workers and entities who adhere to the Ventilator Guidelines in a pandemic.

Moreover, the emergency powers conferred by an emergency declaration may include the authority to suspend application of existing statutes, rules, and regulations for the pendency of the emergency, in order to better respond to the crisis situation (importantly, these emergency procedures generally do not permit the enactment, promulgation, or creation of new laws or suspension of judicial orders or common law). This power is most often considered when implementing mandatory disease isolation or quarantine and compulsory vaccination.

In a pandemic, it may be necessary to temporarily suspend other types of laws and regulations in order to effectively implement guidelines for scarce resource allocation. The New York State Ventilator Allocation Guidelines will be one of the first, and only, documents of its kind to specifically and proactively identify laws that may interfere with effective implementation of ventilator allocation guidelines in a pandemic. These laws may include:

Those that grant patients the rights or benefits associated with certain health care facilities, and give them the ability to bring private actions against those facilities that fail to do so. Such laws might be implicated in an influenza pandemic where patients are removed or refused access to scarce resources pursuant to a state-implemented protocol.

Proxy or surrogate decision-making laws that grant the decision-maker the right to withhold or withdraw life-sustaining treatment on behalf of the patient.

Professional misconduct laws that impose professional discipline, to the extent they would punish compliance with the guidelines.

Penal statutes that could be interpreted to classify withholding or withdrawing a ventilator from a patient pursuant to a state’s scarce resource allocation protocol in a flu pandemic as criminal action.